Photobiomodulation for Management of Temporomandibular Disorder Pain

Photobiomodulation for Management of Temporomandibular Disorder Pain

Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

Inclusion Criteria:

• Male or female, aged 18 years and older
• Meets the CATI pre-screening criteria during pre-screening visit [participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)].
• Willing to provide signed and dated informed consent
• Willing to to comply with all study procedures and to be available for the duration of the study
• Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0
• Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100

Exclusion Criteria:

• Active rheumatologic disease
• Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, or uncontrolled seizures) that precludes participation as determined by the investigator
• Initiated occlusal appliance therapy within 30 days prior to CATI
• Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI
• Is in active orthodontic treatment
• Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI
• Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI
• Has a history of psychiatric hospitalization within one year prior to CATI
• Currently pregnant or lactating
• Has a known hypersensitivity to laser therapy
• Currently being treated with chemotherapy or radiation therapy
• Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit
• Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit.
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator